Afamitresgene Autoleucel (Intravenous)
Afamitresgene autoleucel is an immunotherapy medicine used in adults to treat synovial sarcoma.
Afamitresgene autoleucel is usually given after other treatments have failed.
Your doctor will perform tests to make sure afamitresgene autoleucel is the right treatment for you.
Afamitresgene autoleucel may also be used for purposes not listed in this medication guide.
uses
What is Afamitresgene Autoleucel (Intravenous) used for?
- Soft Tissue Sarcoma
warnings
What is the most important information I should know about Afamitresgene Autoleucel (Intravenous)?
This treatment should not be used if you have a certain gene type. Ask your doctor if you have any questions
Tell your doctor if you have or have ever had:
- an active or recent infection;
- neurologic problems (such as stroke, seizures, memory loss);
- a previous infection or inflammatory condition such as cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection;
- heart problems;
- lung or breathing problems;
- low blood cell counts;
- if you use a blood thinner (such as warfarin) and you have routine "INR" or prothrombin time tests;
- low blood pressure; or
- liver or kidney disease.
Using afamitresgene autoleucel may increase your risk of developing other cancers. Ask your doctor about this risk.
You will need to take a pregnancy test before treatment with afamitresgene autoleucel.
Afamitresgene autoleucel is not recommended in pregnant women. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Afamitresgene Autoleucel (Intravenous)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.
Tell your caregivers or seek emergency medical attention if you have signs of life-threatening neurological problems: problems with speech, problems with thinking or memory, confusion, or a seizure.
Call your doctor at once if you have:
- signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite;
- easy bruising or bleeding, unusual weakness; or
- low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.
Common side effects may include:
- swelling in any part of your body;
- chest pain;
- fast heart rate;
- stomach or back pain;
- trouble breathing;
- low blood cell counts;
- nausea, vomiting, constipation, or diarrhea;
- loss of appetite;
- low blood pressure; or
- fever, chills, tiredness, or other signs of infection.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Afamitresgene Autoleucel (Intravenous) if I’m pregnant or breastfeeding?
You will need to take a pregnancy test before treatment with afamitresgene autoleucel.
Afamitresgene autoleucel is not recommended in pregnant women. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Afamitresgene Autoleucel (Intravenous)?
Avoid driving or hazardous activity for at least 4 weeks after you receive afamitresgene autoleucel.
Do not donate blood, organs, tissues, or cells for transplantation after receiving this medicine.
Dosage Guidelines & Tips
How to take Afamitresgene Autoleucel (Intravenous)?
Use Afamitresgene Autoleucel (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Your blood will be collected in a process called leukapheresis, and your own white blood cells will be used to make afamitresgene autoleucel.
You will not receive the medicine on the same day your blood cells are drawn. Your white blood cells are sent to a laboratory where they are made into afamitresgene autoleucel. The time to process your blood cells into afamitresgene autoleucel can take about 6 weeks.
A second blood collection attempt may be needed to make afamitresgene autoleucel and your treatment plan may be delayed or changed.
About 4 days before afamitresgene autoleucel is given, you will receive chemotherapy to help prepare your body for afamitresgene autoleucel.
You may be given other medications while you are waiting to receive afamitresgene autoleucel to help prevent serious side effects or allergic reaction.
When afamitresgene autoleucel is ready to be given, your dose is injected into a vein by a healthcare provider.
You will be watched closely after receiving afamitresgene autoleucel, and you will be followed up daily at the hospital or clinic for at least 7 days after the infusion to make sure you do not have an allergic reaction or serious side effects.
For at least 4 weeks, you should plan to stay near the hospital or clinic where you received afamitresgene autoleucel.
Your blood will need to be tested often and your doctor will need to check your progress on a regular basis.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using afamitresgene autoleucel.
Call your doctor for instructions if you miss an appointment for your afamitresgene autoleucel injection.
Overdose Signs
What happens if I overdose on Afamitresgene Autoleucel (Intravenous)?
In a medical setting an overdose would be treated quickly.